Delivery Apparatus and Accompanying System for the Application of a Medical Agent to a Treatment Site and Method for Use of Same

ABSTRACT

A medication delivery apparatus and system for the application of a medical agent to a treatment site, such as an airway, and method for use of same are disclosed. In one embodiment of the medication delivery apparatus and system, a reservoir supplies a medical agent to a lower chamber of a housing wherein an ultrasonic transducer applies ultrasonic energy thereto, thereby nebulizing the medical agent. A control valve is interposed between a source of positive pressure air and an upper chamber of the housing to selectively apply positive air pressure to the upper chamber. Upon the application of positive air pressure, the airflow delivers the nebulized medical agent to a target location, such as the airway.

PRIORITY STATEMENT AND CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 14/330,359 entitled “Medication Delivery Apparatusand Accompanying System for the Application of Local Anesthetics to aTreatment Site and Method for Use of Same” and filed on Jul. 14, 2014 inthe name of John S. Houston; which claims priority from U.S. PatentApplication Ser. No. 61/933,654 entitled “Medication Delivery Apparatusand Accompanying System for the Application of Local Anesthetics to anAirway and Method for Use of Same” and filed on Jan. 30, 2014 in thename of John S. Houston; both of which are hereby incorporated byreference for all purposes. This application also claims priority fromU.S. Patent Application Ser. No. 62/102,465 entitled “Delivery Apparatusand Accompanying System for the Application of a Medical Agent to aTreatment Site and Method for Use of Same” and filed on Jan. 12, 2015 inthe name of John S. Houston, which is hereby incorporated by referencefor all purposes.

TECHNICAL FIELD OF THE INVENTION

This invention relates, in general, to systems and methods of treatmentof the living body and apparatus used in the inspection and treatment ofdiseases, wounds, and other abnormal conditions of the bodies of humans,and in particular, to a medication delivery apparatus and accompanyingsystem for the application of local anesthetics to a treatment site anda method for use of the same.

BACKGROUND OF THE INVENTION

Without limiting the scope of the present invention, the background willbe described in relation to treatment of airways, as an example. Anadverse physiological response to laryngoscopic examination and theperformance of procedures on the larynx, trachea, and related anatomicalparts of a patient is common. More specifically, tactile stimulation ofreceptors in the pharynx, hypopharynx, vocal cords, tracheal mucosa andother areas related to an airway often results in reflex gagging,coughing, aspiration, bucking and laryngospasm, for example.Accordingly, laryngoscopic examination and the performance of variousprocedures is typically performed under local anesthesia by theapplication of lidocaine directly onto the larynx. The application oflocal anesthetic, itself, in this manner often causes the patient togag, chock, aspirate, buck and laryngospasm. That is, the application ofthe local anesthetic causes many of the problems it is intended toprevent. Accordingly, a need exists for improvements in the applicationof local anesthesia prior to laryngoscopic examination and relatedprocedures. Further, such need exists beyond the treatment of airways.

SUMMARY OF THE INVENTION

It would be advantageous to achieve advances in medical deliveryinstrumentation to improve the application of local anesthesia prior tolaryngoscopic examination and related procedures. It would also bedesirable to enable a mechanical solution that would improve medicalscience and technique such that the application of local anesthetic,itself, does not cause the patient to gag, chock, aspirate, buck orlaryngospasm. Further, it would be desirous to develop solutions thatextend beyond the treatment of airways. To better address one or more ofthese concerns, a medication delivery apparatus and system for theapplication of a local anesthetic to a treatment site, such as anairway, and method for use of same are disclosed. In one embodiment ofthe medication delivery apparatus, a reservoir supplies a localanesthetic to a lower chamber of a housing wherein an ultrasonictransducer applies ultrasonic energy thereto, thereby nebulizing thelocal anesthetic. A control valve is interposed between a source ofpositive pressure air and an upper chamber of the housing to selectivelyapply positive air pressure to the upper chamber. Upon the applicationof positive air pressure, the airflow delivers the nebulized anestheticto a patient's airway by way of a laryngoscope side port coupling,laryngoscope vacuum port coupling, or catheter coupling, for example.The application of local anesthetic, itself, in this nebulized mannermitigates gaging, chocking, aspirating, bucking and laryngospasms.

In one embodiment of the medication delivery system, a flexibleendoscope having a flexible tubular member having an insertion tip forinsertion into an orifice, such as an airway is utilized in combinationwith the medication delivery apparatus. The various operational statesof the medication delivery apparatus are selectively actuated during theselectively bending of the flexible tubular member. The medicationdelivery system provides for coordinated control of the movement orbending of the flexible endoscope and selective control of theapplication of the local anesthetic. Therefore, the location and amountof local anesthetic applied may be metered to a particular location.

In another embodiment, a medication delivery apparatus and system forthe application of a medical agent to a treatment site, such as anairway, and method for use of same are disclosed. In one embodiment ofthe medication delivery apparatus and system, a reservoir supplies amedical agent to a lower chamber of a housing wherein an ultrasonictransducer applies ultrasonic energy thereto, thereby nebulizing themedical agent. A control valve is interposed between a source ofpositive pressure air and an upper chamber of the housing to selectivelyapply positive air pressure to the upper chamber. Upon the applicationof positive air pressure, the airflow delivers the nebulized medicalagent to a target location, such as the airway. These and other aspectsof the invention will be apparent from and elucidated with reference tothe embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the features and advantages of thepresent invention, reference is now made to the detailed description ofthe invention along with the accompanying figures in which correspondingnumerals in the different figures refer to corresponding parts and inwhich:

FIG. 1A is a side elevation view of one embodiment of a medicationdelivery system, including a flexible endoscope and medication deliveryapparatus, for the application of local anesthetics to a treatment site,such as an airway, being utilized according to the teachings presentedherein on a patient, the airway of which is depicted in cross-section;

FIG. 1B is a front elevation of the medication delivery system depictedin FIG. 1A;

FIG. 1C is a front perspective view of a portion of the medicationdelivery system depicted in FIG. 1A;

FIGS. 2A through 2C are top plan views of the medication delivery systempresented in FIGS. 1A through 1C being utilized, in one embodiment, ondeep vocal folds of the patent;

FIGS. 3A through 3C are side schematic elevation views of the medicationdelivery apparatus depicted in FIGS. 1A and 1B, wherein FIG. 3A depictsthe medication delivery apparatus in an OFF state, FIG. 3B depicts themedication delivery apparatus in a STANDBY state, and FIG. 3C depictsthe medication delivery apparatus in an ON state; and

FIGS. 4A and 4B are side schematic elevation views of another embodimentof the medication delivery apparatus depicted in FIGS. 1A and 1B,wherein FIG. 4A depicts the medication delivery apparatus being loadedand FIG. 4B depicts the medication delivery apparatus loaded and readyfor operation.

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts whichcan be embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention, and do not delimit the scope of the presentinvention.

Referring initially to FIGS. 1A through 1C, therein is depicted amedication delivery system for the application of local anesthetics thatis schematically illustrated and generally designated 10. As shown, themedication delivery system 10, which includes a medication deliveryapparatus 12 and a flexible endoscope 14, is applying the localanesthetic to a patient P, and more particularly, an airway A of thepatient P, with the use of the flexible endoscope 14. It should beappreciated that the teachings presented herein are not limited to thetreatment of an airway, rather the teachings are applicable to anorifice and treatment site, including ear channels, rectums, lungs, andvaginas, for example.

The flexible endoscope 14 is principally constructed of an operationalsection 16 having ends 18, 20. A universal cord 22 extends from theoperational section 16 at the end 18 and an insertion portion 24, whichmay be a flexible tubular member 26, is connected to the end 20 of theoperational section 16. The operational section 16 includes a body 28having a grasping portion 30 configured for an operator's grip, betweenthe ends 18, 20. At the end 18, a vacuum port 32 is provided as arevarious operational control members 34. As shown, in one embodiment, thevarious operational control members 34 may include a bending lever 36that performs bending operations of the insertion portion 24. Anoperation control cluster provides for performing air/water feeding orsuction operations or various operations related to imaging andillumination, for example. A treatment insertion section 40 is locatednear the grasping portion 30 on the body 28 and includes a treatmentinsertion port 42 for inserting various instruments therethrough,including through a treatment insertion channel tube 44 inside theoperating section which is accessed via a branching member 46. A bendpreventing portion 48 is located at the end 20 of the operationalsection 16.

The universal cord 22 may be a composite cable 50 that allows theinsertion therethrough of various signal lines, including a light guidesource 52, for example. More particularly, the universal cord 22includes an endoscope connector 54 that is configured to include anelectronic connection portion 56 on a side portion 58 thereof to whichan electric cable 60 for connection with a video processor may beconnected. A light source connector portion 62 is provided forconnection to a fiber optic cable and an air/water feeding plug 64connects the air/water feeding tube with an air/water feeding apparatus.

As mentioned, the insertion portion 24 includes the flexible tubeportion or flexible tubular member 26 that may be a tubular memberformed with flexibility so as to be passively bendable. As shown, aninsertion tip 66 includes light sources 68, an exit opening 70 to thetreatment insertion channel tube 44, and a camera lens 78, whichprovides optics video to the location of treatment site and ispositioned and communicates with the universal cord 22.

The medication delivery apparatus 12 includes a housing 80 having an airpressure coupling 82 and a medical device coupling 84. An access door 86provides selective access to a re-fillable supply of local anesthetictherein. In one embodiment, the local anesthetic may be lidocaine and,by way of example and not by way of limitation, 4% lidocaine. Asdepicted, the medication delivery apparatus 12 is battery powered. Itshould be appreciated, however, that the medication delivery apparatus12 may be powered by a conventional plug or other technology. Acontroller 88 controls the operation of the medication deliveryapparatus 12. As shown, an air pressure supply 90 is coupled to the airpressure coupling 82. Further, the medical device coupling 84, whichincludes a tubular connector 92, secures the medication deliveryapparatus 12 to the flexible endoscope 14 at the treatment insertionport 42.

It should be appreciated that although one particular flexible endoscopeis depicted, the medication delivery apparatus presented herein may beemployed with a variety of types of flexible endoscopes. Moreover, thecoupling between the medication delivery apparatus and the flexibleendoscope may vary. For example, the medication delivery apparatus maycouple to the flexible endoscope at a vacuum port, such as the vacuumport 32. Such a connection is illustrated by arrow 94. Further, acatheter or other tubular member may be utilized to couple themedication delivery apparatus 12 to the flexible endoscope 14.

In operation, as shown, the insertion portion 24 of the flexibleendoscope 14 is guided into the airway A of the patient P initiallythrough the nasal opening N, which is superior to the oral cavity O. Asdepicted, the insertion tip 66 of the flexible endoscope 14 passes bythe conchae C and epiglottis E to a portion of the airway A proximate tothe laryngeal prominence L and cricoid cartilage R at the trachea T. Asalluded, the bending lever 36 may be manually manipulated by an operatorto guide the flexible endoscope 14. It should be appreciated thatflexible endoscopes have various entries and uses in terms of apatient's body and medicine. Therefore, the illustrated approach doesnot limit other techniques that may be used with the medication deliverysystem 10 presented herein.

Local anesthetic is applied via the selective positioning of theinsertion tip 66 and actuation of the medication delivery apparatus 12by controller 88. When the audio/visual system shows the insertion tip66 is at the desired location, the controller 88 is actuated to providea metered amount of local anesthetic for a controlled duration. Thelocal anesthetic leaves the medication delivery apparatus 12 asnebulized local anesthetic carried by compressed air or another gas, forexample. Depending on the configuration of the coupling between themedication delivery apparatus 12 and the flexible endoscope 14, thenebulized local anesthetic, for example travels through the treatmentinsertion port 42 and through the treatment channel tube 44 via thebranching member 46. The nebulized local anesthetic exits the exitopening 70 of the insertion tip 66 of the insertion portion 24.

More generally, a medication delivery apparatus and system for theapplication of a medical agent to a treatment site and method for use ofsame are disclosed that may have applications beyond airways and theapplication of a local anesthetic. In one embodiment, a medial agent,which may be a local anesthetic, is nebulized and applied to a targetsite. In addition to a local anesthetic, the medical agent may be anagent including, steroids, antibiotics, anti-fungal agents,anti-bacterial agents, antiviral agents, hormones, antihistamines,non-steroidal anti-inflammatories, or glucocorticoids, corticosteroids,chemotherapeutic agents, and vasodilating anesthetics, for example.Further, the medication delivery device may be used with medical devicesother than flexible endoscopes, including laryngoscopes via sidechannels, flexible endoscopes, flexible laparoscopes or any tube,channel, or pipette, which is attached to the medication deliveryapparatus to deliver the medical agent to the target site.

FIGS. 2A through 2C depict the medication delivery system 10 beingutilized on deep vocal folds L1, L2 within the airway A of the patientP. It should be appreciated that although the deep vocal folds areillustrated, any orifice in the body or open surgical site may be thetarget site. Further, although FIGS. 2A through 2C are illustrated anddescribed with respect to lidocaine and a flexible endoscope, theaforementioned other medical agents and medical devices may be utilizedwith the medication deliver system presented herein. As shown, themedication delivery system 10 and, in particular, the insertion portion24 of the flexible endoscope 14 is positioned in the airway A of thepatient P such that the insertion tip 66 is positioned proximate to thevocal fold L1 in FIGS. 2A and 2B and proximate to the vocal fold L2 inFIG. 2C. In FIG. 2A, local anesthetic is not provided. In thisoperational state, a nebulized local anesthetic is produced within themedication delivery apparatus 12, which remains in the medicationdelivery apparatus 12.

In FIG. 2B, however, the medical delivery system provides a meteredamount of local anesthetic for a controlled duration of time as shown bynebulized local anesthetic 100. As previously discussed, the nebulizedlocal anesthetic 100 is delivered from the medication delivery apparatus12 to the flexible endoscope 14 and, in particular, the treatmentchannel tube 44 of the insertion portion 24, where the nebulized localanesthetic 100, which may be lidocaine or other suitable anesthetic,exits the flexible endoscope 14 at exit opening 70. In the nebulizedform described herein, the local anesthetic 100 is visible and, inparticular, visible in using the optical capabilities of the endoscope12. Following the delivery of the controlled amount of nebulized localanesthetic, no anesthetic is provided as the flexible endoscope 14 isrepositioned to a location proximate vocal fold L2, as shown in FIG. 2C.At FIG. 2C, a metered amount of nebulized local anesthetic 100 isprovided in a manner that permits the local anesthetic to be visiblypainted onto the treatment site in a controlled manner. In theseoperational states whereby, the local anesthetic supplied to themedication delivery apparatus 12 is nebulized and carried by theapplication of air into the airway A of the patient P.

It should be appreciated that the various operational states of themedication delivery apparatus 12 are selectively actuated during theselectively bending of the flexible tubular member 24. As previouslydiscussed, an adverse physiological response to laryngoscopicexamination and the performance of procedures on the larynx, trachea,and related anatomical parts of a patient, such as the patient P, iscommon. More specifically, tactile stimulation of receptors in thepharynx, hypopharynx, vocal cords, tracheal mucosa and other areasrelated to the airway A often results in reflex gagging, coughing,aspiration, bucking and laryngospasm, for example. Accordingly,laryngoscopic examination and the performance of various procedures istypically performed under local anesthesia by the application lidocainedirectly onto the larynx. By way of the medication delivery system, theapplication of local anesthetic, itself, mitigates gagging, chocking,aspirating, bucking or laryngospasms in a patient as the delivery of thelocal anesthetic is in a controllable metered and nebulized form; ratherthan an uncontrollable stream of a liquid.

Referring now to FIGS. 3A through 3C, wherein the medication deliveryapparatus 12 is depicted in additional detail. More particularly, FIG.3A depicts the medication delivery apparatus 12 in an OFF state, FIG. 3Bdepicts the medication delivery apparatus 12 in a STANDBY state, andFIG. 3C depicts the medication delivery apparatus 12 in an ON state. Themedical delivery apparatus 12 includes a reservoir 110 configured tocontain the local anesthetic 100, which is referred to as localanesthetic 100 whether in a liquid or nebulized state. The reservoir mayinclude a volume from about 5 ml to about 200 ml. A heating element 111may be associated with the reservoir 110 and positioned at the bottomthereof. In one embodiment, the heating element 111 is configured toheat the local anesthetic to a temperature that is comfortable andappropriate for contact with the airway A of the patient P. In oneimplementation, the heating element 111 may heat the local anesthetic toa temperature from about 50° F. (10° C.) to about 105° F. (40.5° C.). Byway of example and not by way of limitation, the heating element 111 maybe a heating coil. As shown, the reservoir 110 is disposed in fluidcommunication with a supply channel 112 and a circulation channel 114. Anebulization housing 116 includes a lower chamber 118 and an upperchamber 120. In one implementation, the lower chamber 118 and the upperchamber 120 form integral portions of the nebulization housing 116. Thelower chamber 118 is disposed in fluid communication with the supplychannel 112 and the circulation channel 114. A fluid circuit 125 isthereby formed by the flow of local anesthetic from the reservoir 110 tothe supply channel 112 to the lower chamber 118 to the circulationchannel 114. Further, in one embodiment, the heating element may beassociated with the lower chamber 118, supply channel 112 or thecirculation channel 114, for example.

The upper chamber 120 is disposed in fluid communication with an airflowchannel 122 and a delivery channel 124. An ultrasonic transducer 126 ispositioned in the lower chamber 118 in order to generate, uponenergization, ultrasonic energy, which nebulizes the local anesthetic100. In one implementation, the ultrasonic transducer 126 may be apiezoelectric transducer that provides ultrasonic waves. In particular,by way of example and not by way of limitation the piezoelectrictransducer may be a 40 KHz to about 2.5 MHz. A control valve 128 isinterposed between a source of positive pressure air connected to airpressure coupling 82 and the airflow channel 122. In one embodiment, thecontrol valve may be a 0.2 lbs to 250 lbs pressure regulator and thesource of positive pressure air may be an air compressor or storagetank. In one implementation, the source of positive air pressureprovides air pressure from about 0.2 psi to about 25 psi. As shown, by acomparison of FIGS. 3A through 3C, the control valve 128, which ismanipulated by the controller 88, is configured to selectively apply airto the airflow channel 122. A medical device coupling 84 is located at adistal end of the delivery channel 124. In one implementation, themedical device coupling 84 may be selected from the group oflaryngoscope side port couplings, laryngoscope vacuum port couplings,and catheter couplings.

Referring now to FIG. 3A, in an OFF operational state, the localanesthetic 100 remains in the reservoir 110 and is not circulated fromthe reservoir 110 to the lower chamber 118. Further, the source of airpressure is not providing positive air pressure to the upper chamber 120of the nebulization housing 116 as the control valve 128 is set to blockairflow therethrough. As shown by arrow 132, the air flow only reachesthe control valve 128 and does not pass therethrough. Referring now toFIG. 3B, in a STANDBY operational state, the local anesthetic 100 iscirculated initially from the reservoir 110, where heating element 111provides heat such that the local anesthetic 100 will be an agreeableand appropriate temperature to patient P. From the reservoir 110, thelocal anesthetic 100 continues through the fluid circuit 125 to thelower chamber 118, wherein the ultrasonic transducer applies ultrasonicenergy 130 to the local anesthetic 100, thereby producing a nebulizedlocal anesthetic 100 which remains in the upper chamber 120. In thisoperational state, the control valve 128 is positioned to block the flowof air from the source of pressurized air 90 to the upper chamber 120and the delivery channel 124. As shown, the fluid circuit 125 provides areturn path for the local anesthetic 100 from the nebulization housing116 to the reservoir 110 via the circulation channel 114. It should beappreciated that the reservoir 110 may be accessed by access door 86 tore-fill the supply of anesthetic. Further, various electronic elementssuch as a power supply may be included with the medication deliveryapparatus 12, but are not shown.

Referring now to FIG. 3C, the medication delivery apparatus 12 is in anON operational state, wherein the local anesthetic 100 is circulatedfrom the reservoir 110 to the lower chamber 118 of the nebulizationhousing 116 through the fluid circuit 125. Within the lower chamber 118of the nebulization housing 116, the ultrasonic transducer 126 appliesultrasonic energy 130 to the local anesthetic 100, thereby producing anebulized local anesthetic 100 which is carried by the application ofair, as shown by arrows 132, 134 to the delivery channel 124, as shownby arrow 136. In this operational state, the control valve 128 permitsthe flow of pressurized air from the air source to the upper chamber 120and the delivery channel 124 and onto the airway A of the patient P, forexample. As shown by comparing FIGS. 3B and 3C, via the controller 88and control valve 128, the application of local anesthetic may beselectively controlled to provide targeted and metered amounts of localanesthetic. It should be appreciated that although not shown, thecontrol valve 128 may be under the control of the controller 88.

In one particular embodiment, a valve 138, which may be a check valve,is positioned within the delivery channel 124. In the presence ofnegative pressure from the medical device coupling 84, the valve 138closes in order to prevent the local anesthetic 100 from being pulledout of the housing 80 of the medication delivery apparatus 12. In oneapplication, as alluded to, the medication delivery apparatus 12 may becoupled to the flexible endoscope 14 at the treatment insertion section40. In this configuration, a vacuum (VAC), see FIG. 1B, may be appliedat the vacuum port 32 and via control of the vacuum (VAC), themedication delivery apparatus 12 may be operated between the ONoperational state and an EFFECTIVE STANDBY operational state, wherebythe presence of the negative pressure by way of the vacuum port 32causes the valve 138 to close and prevents the flow of the localanesthetic 100 from exiting the delivery channel 124. That is, the ONoperational state and the EFFECTIVE STANDBY operational state areselected by the state of the valve 138 such that the valve 138 closingin response to negative pressure at the vacuum port 32, e.g., theapplication of a vacuum (VAC) causes the EFFECTIVE STANDBY operationalstate.

In other conditions, if power is provided to the medication deliveryapparatus 12, then the ON operational state is selected. Further, inthis implementation with the medication delivery apparatus 12 coupled tothe flexible endoscope 14 at the treatment insertion port 42 to providefor use of a vacuum (VAC) at the vacuum port 32, the action of thevacuum (VAC) performs the additional function of removing an excesslocal anesthetic 100 and/or other bodily fluids during actuation at theEFFECTIVE STANDBY operational state. This provides additional medicalefficacy.

Referring now to FIGS. 4A and 4B, another embodiment of a medicationdelivery apparatus 150 for the application of a local anesthetic to atreatment site is shown. An inner housing 152 is releasably engageablewith an outer housing 154 as shown by arrow 156. Upon engagement,coupling member 158, which is connected to the airflow channel 122, andcoupling member 160, which is connected to the delivery channel 124 maybe connected to the medication delivery apparatus 150. As previouslydiscussed, a medical device coupling may be located at a distal end ofthe delivery channel 124. In one implementation, the medication deliveryapparatus 150 provides a disposable inner housing 152, which contains ameasure of the local anesthetic that is releasably engageable with theouter housing 154. After a use, the inner housing 152 may be removed anda new inner housing or cartridge may be loaded.

With respect to the inner housing 152, an exterior wall 162, whichdefines a reservoir, has a sidewall and base and includes openings 164,166 therethrough. Mechanical connectors 168, 170 extend from theexterior wall 162 in order to form a mechanical connection with theouter housing 154. By way of example, and not by way of limitation, themechanical connection may be a bayonet connection, a male-female pin andbox connection, snap-fit engagement, or other type of connection. Theultrasonic transducer 126 is located within the interior housing 152 andincludes prongs 172, 174 extending therefrom. As previously discussed,the ultrasonic transducer 126 is configured to generate, uponenergization, ultrasonic energy. In one implementation, the prongs 172,174 coupled the ultrasonic transducer 126 to a source of power withinthe outer housing 154.

The outer housing 154 includes a receiving chamber 182 with openings184, 186 traversing therethrough to provide for mating connections withthe coupling members 158, 160. Receivers 188, 190 are positioned toreceive the mechanical connectors 168, 170 and form a releasableconnection therewith. Receivers 192, 194 mate with the prongs 172, 174to provide the aforementioned source of power to the ultrasonictransducer 126. In one implementation, the prongs 172, 174 and thereceivers 192, 194 are not required as the ultrasonic transducer 126includes a power supply, such as a battery that may be actuated by abutton or other feature on the outer housing 154. Heating elements 196,198 may be positioned within the outer housing to selectively supply asource of heat to the local anesthetic 100. Similar to the power supply,the heating source may be included in the inner housing 152 in anotherembodiment.

In operation, the inner housing 152 is configured to insert into thereceiving chamber 182 of the outer housing 154 and releasably engagetherewith, thereby defining an engaged position between the innerhousing 152 and the outer housing 154. In the engaged position, theupper channel, as defined by arrows 134, 135, and 136, is disposed influid communication with the airflow channel 122 and the deliverychannel 124. In a first operational state, such as ON, of the medicationdelivery apparatus 150, a source of positive pressure air traverses theupper channel, as represented by arrows 134, 135, 136, wherein theultrasonic transducer 126 applies ultrasonic energy to the localanesthetic 100, thereby producing a nebulized local anesthetic 100 whichis carried by the application of air to the delivery channel 124,similar to FIG. 3A.

In a second operational state, such as EFFECTIVE STANDBY, similar toFIG. 3B, of the medication delivery apparatus 150, wherein theultrasonic transducer 126 applies ultrasonic energy to the localanesthetic 100, thereby producing a nebulized local anesthetic, whichremains in the inner housing. In the embodiments of FIGS. 4A and 4B, theON operational state and the EFFECTIVE STANDBY operational state may beselected by any technique including the state of a valve, such as thevalve 138 in FIGS. 3A through 3C, such that the valve 138 closing inresponse to negative pressure at the vacuum port, e.g., the applicationof a vacuum (VAC) causes the EFFECTIVE STANDBY operational state.

The order of execution or performance of the methods and operationsillustrated and described herein is not essential, unless otherwisespecified. That is, elements of the methods and flows may be performedin any order, unless otherwise specified, and that the methods mayinclude more or less elements than those disclosed herein. For example,it is contemplated that executing or performing a particular stepbefore, contemporaneously with, or after another step are all possiblesequences of execution.

While this invention has been described with reference to illustrativeembodiments, this description is not intended to be construed in alimiting sense. Various modifications and combinations of theillustrative embodiments as well as other embodiments of the invention,will be apparent to persons skilled in the art upon reference to thedescription. It is, therefore, intended that the appended claimsencompass any such modifications or embodiments.

What is claimed is:
 1. A delivery apparatus for the application of amedical agent to a treatment site, the medication delivery apparatuscomprising: a reservoir configured to contain the medical agent, thereservoir disposed in fluid communication with a supply channel and acirculation channel; a nebulization housing including a lower chamberand an upper chamber; the lower chamber being disposed in fluidcommunication with the supply channel and the circulation channel; theupper channel being disposed in fluid communication with an airflowchannel and a delivery channel; an ultrasonic transducer positioned inthe lower chamber, the ultrasonic transducer configured to generate,upon energization, ultrasonic energy; a control valve interposed betweena source of positive pressure air and the airflow channel, the controlvalve configured to selectively apply air to the airflow channel; afirst operational state of the control valve wherein the medical agentis circulated from the reservoir to the lower chamber, wherein theultrasonic transducer applies ultrasonic energy to the medical agent,thereby producing a nebulized medical agent which is carried by theapplication of air to the delivery channel; and a second operationalstate of the control valve wherein the local anesthetic is circulatedfrom the reservoir to the lower chamber, wherein the ultrasonictransducer applies ultrasonic energy to the local anesthetic, therebyproducing a nebulized medical agent which remains in the upper chamber.2. The delivery apparatus as recited in claim 1, wherein the medicalagent further comprises a local anesthetic.
 3. The medication deliveryapparatus as recited in claim 1, wherein the medial agent local furthercomprises an agent selected from the group consisting of steroids,antibiotics, anti-fungal agents, anti-bacterial agents, antiviralagents, hormones, antihistamines, non-steroidal anti-inflammatories,glucocorticoids, corticosteroids, chemotherapeutic agents, andvasodilating anesthetics.
 4. The medication delivery apparatus asrecited in claim 1, wherein the reservoir comprises a volume from about5 ml to about 250 ml.
 5. The medication delivery apparatus as recited inclaim 1, further comprising a heating element associated with thereservoir, the heating element heating the medical agent.
 6. Themedication delivery apparatus as recited in claim 1, further comprisinga heating element associated with the reservoir, the heating elementheating the medical agent to a temperature from about 50° F. (10° C.) toabout 105° F. (40.5° C.).
 7. The medication delivery apparatus asrecited in claim 1, further comprising a heating element associated withthe reservoir, the heating element being a heating coil.
 8. Themedication delivery apparatus as recited in claim 1, wherein the lowerchamber and the upper chamber are integrally formed as a single chamber.9. The medication delivery apparatus as recited in claim 1, wherein thelower chamber comprises a volume from about 5 ml to about 250 ml. 10.The medication delivery apparatus as recited in claim 1, wherein theupper chamber comprises a volume from about 5 ml to about 250 ml. 11.The medication delivery apparatus as recited in claim 1, furthercomprising a fluid circuit providing circulation from the reservoir tothe supply channel to the lower chamber to the circulation chamber tothe reservoir.
 12. The medication delivery apparatus as recited in claim1, wherein the ultrasonic transducer further comprises a device thatuses a piezoelectric transducer to produce ultrasonic waves.
 13. Themedication delivery apparatus as recited in claim 1, wherein theultrasonic transducer further comprises 40 KHz to 2.5 MHz.
 14. Themedication delivery apparatus as recited in claim 1, wherein the controlvalve further comprises 0.2 lbs to 250 lbs pressure regulator.
 15. Themedication delivery apparatus as recited in claim 1, wherein the sourceof positive pressure air further comprises an air compressor.
 16. Themedication delivery apparatus as recited in claim 1, wherein the sourceof positive pressure air further comprises air pressure from about 0.2lbs. psi to 25 lbs. psi.
 17. A medication delivery apparatus for theapplication of a medical agent to a treatment site, the medicationdelivery apparatus comprising: an outer housing having a receivingchamber; an inner housing configured to insert into the receivingchamber of the outer housing and releasably engage therewith, the innerhousing thereby having an engaged position within the outer housing; theinner housing including a reservoir configured to contain the localanesthetic; an upper channel being disposed in fluid communication withan airflow channel and a delivery channel, the upper channeltransversing the outer housing and the inner housing in the engagedposition; an ultrasonic transducer positioned in the inner housing, theultrasonic transducer configured to generate, upon energization,ultrasonic energy; a first operational state of the medication deliveryapparatus wherein a source of positive pressure air traverses the upperchannel, wherein the ultrasonic transducer applies ultrasonic energy tothe medical agent, thereby producing a nebulized local anesthetic whichis carried by the application of air to the delivery channel; and asecond operational state of the medication delivery apparatus, whereinthe ultrasonic transducer applies ultrasonic energy to the medicalagent, thereby producing a nebulized local anesthetic which remains inthe inner housing.
 18. The delivery apparatus as recited in claim 17,wherein the medical agent further comprises a local anesthetic.
 19. Themedication delivery apparatus as recited in claim 17, wherein the medialagent further comprises an agent selected from the group consisting ofsteroids, antibiotics, anti-fungal agents, anti-bacterial agents,antiviral agents, hormones, antihistamines, non-steroidalanti-inflammatories, and glucocorticoids, corticosteroids,chemotherapeutic agents, and vasodilating anesthetics.
 20. Themedication delivery apparatus as recited in claim 17, wherein thereservoir comprises a volume from about 5 ml to about 250 ml.